Spine Surgery

A new study in the journal Spine shows that in many cases surgery can even backfire, leaving patients in more pain.

Researchers reviewed records from 1,450 patients in the Ohio Bureau of Workers’ Compensation database who had diagnoses of disc degeneration, disc herniation or radiculopathy, a nerve condition that causes tingling and weakness of the limbs. Half of the patients had surgery to fuse two or more vertebrae in hopes of curing low back pain. The other half had no surgery, even though they had comparable diagnoses.

After two years, just 26 percent of those who had surgery returned to work. That’s compared to 67 percent ofpatients who didn’t have surgery. In what might be the most troubling study finding, researchers determined that there was a 41 percent increase in the use of painkillers, specifically opiates, in those who had surgery.

The study provides clear evidence that for many patients, fusion surgeries designed to alleviate pain from degenerating discs don’t work, says the study’s lead author Dr. Trang Nguyen, a researcher at the University of Cincinnati College of Medicine.

 Unfortunately, for most patients with bad backs, there is no easy solution, no magic bullet. Pain management experts — and some surgeons — say that patients need to scale back their expectations. With the right treatments, pain can be eased, but a complete cure is unlikely.

In the wake of her operations, Scatena has turned to less invasive therapies. She’s learned to baby her back and to find ways to avoid irritating the nerves in her spine. She’s working to strengthen muscles in her lower back and abdomen so her spine will get better support. “I’ve been getting some relief from physical therapy,” she says. “And I hope that’s going to be permanent.”

27 million adults with back problems 
A recent report by the Agency for Healthcare Research and Quality, a federal organization, found that in 2007, 27 million adults reported back problems with $30.3 billion spent on treatments to ease the pain. While some of that money is spent on physical therapy, pain management, chiropractor visits, and other non invasive therapies, a big chunk pays for spine surgeries.

Complicated spine surgeries that involve fusing two or more vertebrae are on the rise. In just 15 years, there was an eight-fold jump in this type of operation, according to a study published in Spine in July. That has some surgeons and public health experts concerned.

For some patients, there is a legitimate need for spine surgery and fusion, says Dr. Charles Burton, medical director for The Center for Restorative Spine Surgery in St. Paul, Minn. “But the concern is that it’s gotten way beyond what is reasonable or necessary. There are some areas of the country where the rate of spine surgery is three or four times the national average.”

Burton and others recommend that patients get a second opinion when back surgery is recommended for the treatment of back pain without neurological symptoms, such as sciatica, especially if other treatments haven’t been suggested first.

“We are very successful at improving leg symptoms," says Dr. William Welch, vice chairman of the department of neurosurgery at the University of Pennsylvania Medical Center and chief of neurosurgery at Pennsylvania Hospital. “We are less successful at treating back pain.”

Source of pain is often hard to pinpoint 
The reason, Welch says, is that it’s often hard to pinpoint the exact cause of someone’s back pain. Even MRIs can be misleading because abnormalities, such as degenerating discs, can be seen on scans for virtually everyone over the age of 30 regardless of whether they have pain. Even when the surgery is a success, it rarely dispels 100 percent of back pain, Welch says.

And while many surgeons are careful about which patients they recommend for spine operations, some are not so discriminating, says Dr. Doris K. Cope, professor and vice chair for pain medicine at the University of Pittsburgh School of Medicine. “It’s a case of, if you have a hammer, everything looks like a nail,” she explains.

In general, the best results come about through a combination of approaches, Cope says. Each strategy may reduce pain by just 10 or 20 percent, but those percentages can add up so ultimately the patient’s pain is cut back by as much as 70 or 80 percent. Strategies can include exercise and weight loss, Cope says.

That advice resonates with Marilyn Seiger, a friend of Nancy Scatena in Scottsdale. Seiger opted to skip surgery, not wanting to follow her friend's painful path, even though her doctor recommended an operation to fuse two of her vertebrae.

She has gotten some relief from physical therapy, a back brace that reminds her to keep her back straight, and the occasional pain pill.

“I don’t know anyone who’s had surgery for back pain who had success,” says Seiger, 61. “I just figure this is part of growing older. We’re living longer than our bodies were meant to last and we’re just constantly shoring things up.”

© 2010 msnbc.com.  Reprints

Roughly 200,000 people in the U.S. undergo spinal fusion surgery each year.

Evidence is the password to all that is scientific in medicine. 

For better or worse -- and largely for better -- we have all come to rely on the evidence when we make medical choices, and presume that our physicians are relying on evidence when we are offered options.

Evidence that we are not fooling ourselves or being fooled has been a grail of philosophers for centuries.

But today the focus is on drugs, particularly new drugs.

Most of medicine escaped this new level of oversight and still does. In particular, procedures fall out of the purview of the FDA unless the procedure involves placing some substance or widget into the body, and then the test relates more to safety than evidence of efficacy.

Is Surgery Always Best?
Most surgery is not "evidence-based;" it remains eminence-based, dripping with hubris.

For necessary surgery, there may be no better way than to turn than to experienced surgeons who hold survival in their hands. To their credit, surgeons are willing to make head-to-head comparisons of different approaches.

Of course, it would be unconscionable not to do what is considered, at least by some, to be the best in any desperate situation. Spine surgeons can be heroes in this regard, when it comes to stabilizing fractured or tumor-riddled spines.

But most surgery today is "elective." It is not necessary, because it is not certain that you will be better off for it, or worse off without it.

Slowly but surely, elective surgery is being subjected to studies designed to generate evidence necessary to make an informed decision. But with very rare exception, all these studies are seriously flawed by avoiding the most stringent test of efficacy.

These studies compare one procedure with another, or one procedure with a nonsurgical therapy. But the only true test of elective surgery is to compare the surgery that is believed to work with a sham procedure.

You heard me right. When this has been done for angina and for knee pain, the sham procedure is at least as good as the one thought to have worked.

I have no problem with a study that informs the volunteers that they are likely to have a sham procedure. In fact, I'm troubled that such is not commonplace.

The Back Surgery Debacle

Nearly all surgery for regional back disorders is elective. I coined the term regional back disorders for an editorial in the New England Journal of Medicine 20 years ago. It denotes the back pain and other symptoms that afflict adults who are otherwise well, who have suffered no overt trauma, and who have no major neurological complication.

Depending on where you live in the country, you can run a 10-fold greater risk of being offered and accepting surgery for a regional back disorder than if you live in any other country. It's open season on the American spine.

Nearly all this surgery is for low back pain. Spine surgeons have long felt beleaguered by critics such as me. After all, there have been a number of studies, mainly from Europe, that fail to generate an iota of evidence for any benefit from any form of spine surgery for regional low back pain. For workers' compensation claimants, surgery is likely to leave you worse off.

If you are offered any form of surgery for regional low back pain, please ask for the evidence. Before you agree to the surgery, ask whether you are likely to do as well without it. To my way of thinking, if elective surgery for regional back pain were a pharmaceutical it wouldn't be licensed.

Few spine surgeons appreciate me for my way of thinking. I have some empathy. Years of technical training and the development of a special surgical perspective are trumped by the evidence. No wonder the two papers in a recent New England Journal of Medicine were met by fanfare in the press, and celebration in the spine surgery community.

Neither paper has anything to do with regional low back pain -- my forewarning still pertains. Each tackles a special regional low back disorder that need not cause low back pain, but is characterized by pain into the buttocks or legs.

One paper is an analysis of a subset of patients in a very large American randomized trial comparing surgery with medical treatment for various regional back disorders. This brilliantly designed trial was bedeviled by our cherished patient autonomy; many of the volunteers refused to stay with the treatment to which they were randomized. There was so much crossover that I'm sure the statisticians suffered indigestion. They massaged the data nonetheless and still could find no joy from surgery for regional low back pain.

Then they came up with this subset. It took four years for the doctors in 13 centers in 11 states to find 600 patients who had persistent pain into the buttocks or a leg when they walked and had very impressive degenerative changes in their spinal anatomy -- a combination that is considered a special disorder, "spinal stenosis."

The surgical remedy is somewhat drastic, particularly for a population that tends to be elderly and even frail. It usually involves fusing the spine and is associated with greater than 10 percent incidence of important complications.

The analysis suggests benefit of the surgery. I will accept that result only because of a similar trial from Finland with far less crossover. In the Finnish trial, patients improved regardless of the treatment. Those with the surgery reported a bit less discomfort but no more mobility.

If I develop spinal stenosis, I wouldn't let you operate on me for that piddling outcome. I'd swallow my pride and walk bent over a walker (which usually alleviates these symptoms) before I'd risk surgery.

The other paper is one of many looking at patients with sciatica: pain down the leg with or without back pain.

Most get better too quickly to justify surgery, even in America. For those who are hurting for a couple of months, surgery has something to offer. They are more likely to be better once they recover from the surgery than patients treated medically, though the medically treated patients catch up by year's end.

That's not much to write home about. I'd need to see a sham control before I'd believe the "surgery for subacute sciatica" mantra.

Based on the evidence, the currently available surgical remedies for regional spine disorders belong next to tonsillectomy in the archives.

Dr. Nortin Hadler is professor of medicine and microbiology/immunology at the University of North Carolina at Chapel Hill, and an attending rheumatologist at University of North Carolina Hospitals. He is the author of The Last Well Person.

Surgical Studies A large study by Dvorak J. et al. reviewed the long-term results of patients that had received surgery for lumbar disc herniations . They reported that of the 575 patient’s studied, 70% still complained of back pain; 83% complained of constant heavy pain; 45% have a residual sciatica; 35% are still under some kind of treatment; 47% are receiving a disability pension and 17% required repeat surgeries. The authors stated “Based upon the criteria given by Spine as related to justified or unjustified indication, there was no statistical difference in long-term results for surgery as compared to conservative care”. “The so-called justified indication for disc herniation neurosurgery does not necessarily imply a good long term result.”

The overuse of surgery has been perhaps the single most damaging medical intervention for back pain sufferers. Bigos and Battie reported, “Surgery seems helpful for at most 2% of patients with back problems, and its inappropriate use can have a great impact on increasing the chance of chronic back pain disability.

In a Volvo award winning paper, Waddell reports, “Dramatic surgical success unfortunately only applies to approximately 1% of patients with low back disorders. Our failure involves the remaining 99% . . . for whom the problem has become progressively worse.”

Saal and Saal supervised care for a group of patients referred by neurologists for surgery. They attempted rehabilitation for these patients and made the following observations: “Surgery should be reserved for those patients for whom function cannot be satisfactorily improved by a physical rehabilitation program . Failure of passive non-operative treatment is not sufficient for the decision to operate.” They also reported that, “the premise that operative patients fare better in the first year is contrary to our results, and the notion that surgery is necessary in a patient with a large disk extrusion is not supported in the literature. The presence of a disk extrusion does not adversely effect the outcome of non-operative treatment and should not be used as overwhelming evidence that surgery is necessary”.

In 1983, Weber reported that, even in properly selected patients, there is no difference in outcome between surgically and conservatively treated patients at two years.

In 1992, Bush et al stated that, “86% of patients with clinical sciatica and radiologic evidence of nerve root entrapment were treated successfully by aggressive conservative management.” They reported that, “the intervertebral disc pathomorphology that might seem best suited to surgical resection is in fact that which shows the most significant incidence of natural regression. . .these results confirm that if the pain can be controlled, nature can be allowed to run its course with the partial or complete resolution of the mechanical factor . . .lumbar herniated nucleus pulposus can be treated non-operatively with a high degree of success.”

Bush et al also stated that ‘Surgery clearly has its place in the treatment of lumbar spine disorders. Conservative care practitioners must be able to select the patients who satisfy the criteria for surgical intervention. These criteria are more strict than previously believed.

EPIDURALS: HOW EFFECTIVE? Epidural Steroid Injections: Epidural corticosteroid injections have been used have been used for nearly half a century and are widely used in everyday clinical practice. They may be helpful for reducing tissue inflammation and short-term pain relief in a patient with an acute radicular low back problem who is unable to participate in an active treatment program because of severe leg pain and/or neuromotor deficit.

In randomized, double blind trials, patients were given up to three epidural injections of corticosteroids versus saline . After three months, there were no significant differences between the groups. The authors concluded that “although epidural injections may afford short-term improvement in leg pain, this treatment offers no significant functional benefit, nor does it reduce the need for surgery.”

A recent randomized double-blind trial published in the Annals of Rheumatic diseases (2003) concluded that steroid injections for sciatica are no better than saline. These findings are consistent with those of another definitive trial presented at the recent American College of Rheumatology meeting.

Lumbar Support Belts: According to a large new prospective cohort study conducted by researchers at the National Institute of Occupational Safety and Health, lumbar support belts do not prevent back pain or back pain disability. In the largest prospective study of back belt use, adjusted for multiple individual risk factors, neither frequent belt use nor a store policy that required belt use was associated with reduced incidence of back injury claims or low back pain. The study found no beneficial effect of belt use in any group: among employees with and without a history of back injury, employees with consistent belt-wearing habits, or employees with the most strenuous jobs.

Results based on multiple studies all converge to a common conclusion: back belt use is not associated with reduced incidence of back injury claims or low back pain in material handlers.